Flexible surgical device having a rotatable end effector assembly

ABSTRACT

A flexible clip applier includes a flat wire wound tubular coil, a pair of jaws at the end of the coil, end effector wires extending through the coil and coupled to the jaws, and a clip-advancing wire extending through the coil. A clip chamber is defined in the distal end of the coil. The clip-advancing wire includes a clip pusher which advances a clip into the jaws when the clip-advancing wire is moved distally. The jaws include channels in which a distalmost clip rides when the jaws are closed and the pusher is advanced, thereby causing the distalmost clip to be pushed over the tissue, and a distal anvil which operate to bend a portion of the clip to facilitate its retention on the clamped tissue. Rotation of the clip-advancing wire effects rotation of the jaws are rotatable about a longitudinal axis of the device.

[0001] This application is a continuation-in-part of U.S. Ser. No.09/891,775, filed Jun. 25, 2001, which is hereby incorporated byreference herein in its entirety.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] This invention relates broadly to surgical devices. Inparticular, this invention relates to a flexible surgical device havingend effectors rotatable about a longitudinal axis of the device. Moreparticularly, this invention relates to a surgical clip applier which isadapted for use through an endoscope and may be used to clamp and/orsuture, ducts, vessels, and other tissues, to anchor a tissue, or toattach a foreign body to a tissue.

[0004] 2. State of the Art

[0005] Surgical clips are generally used to apply clamping force toducts, vessels, and other tissues. In addition, surgical clips areparticularly useful in controlling bleeding of a tissue in lieu ofsuturing or stapling where suturing or stapling is difficult.

[0006] All of the currently available surgical multifiring clip appliersare substantially rigid devices intended to extend through a trocar portor through an incision to a surgical site requiring application of aclip. The devices have been rigid because a stiff pushing element hasbeen required in order to exert the required pushing force to move theclip over the tissue.

[0007] However, there is a substantial need for a flexible clip applier,particularly one insertable through a lumen of an endoscope. The abilityto apply clips through an endoscope would permit myriad minimallyinvasive surgical solutions to medical problems, especially those of thegastrointestinal tract. However, it is accepted theory that thetransmitted force required to advance or form a clip over tissue cannotbe produced in the distalmost end of a long flexible device that iscommonly constructed with a metal tubular coil, or polymer tube, such asan endoscopic device or catheter. For example, C. Paul Swain, MD, arecognized expert in endoscopic instruments and particularly endoscopicstapling devices, has stated that “[i]t is hard to exert more than 200 gof force on the tissue when pushing . . . . This fact is of course onefeature that makes intervention at flexible endoscopy relatively safe”.See C. Paul Swain, “What Endoscopic Accessories Do We Really Need?”,Emerging Technologies in Gastrointestinal Endoscopy, Gastrointest.Endosc., Vol. 7, No. 2, pp. 313-330 (April 1997). Yet, a pushing forcesubstantially greater than 200 g is required to push a clip overcompressed tissue. In fact, it is believed a force in excess of 500grams (1.1 lbs) is required for a satisfactory instrument, andsubstantially greater forces, e.g., in excess of 1500 grams (3.3 lbs)would be desirable.

[0008] Generally a flexible endoscopic device (e.g., a biopsy forcepsdevice) includes an outer tubular member, typically being constructed ofa metal tubular coil or a polymer tube which is poor in transmittingforces that impart tensile stresses to the outer sheath, a controlelement longitudinally movable relative to the tubular member, an endeffector coupled to the distal ends of both the tubular member and thecontrol element such that relative movement of the control element andthe tubular member causes operation of the end effector, and a handlewhich moves the control element relative to the handle. This type offlexible endoscopic instrument is limited in the amount of pushing forceit can generate for several reasons. Compression of a flexible controlelement (pushing element) tends to cause the pushing element to bucklewithin the outer flexible sheath of the device. If a relatively largerdiameter flexible pushing element is used such that it better resistsbuckling, the pushing element may impart too much stiffness to theflexing of the endoscopic instrument. In addition, a flexible pushingelement of larger diameter is subject to greater frictional forceswithin the outer sheath which reduces the force transmitted from thehandle to the end effector. If the flexible pushing element is maderelatively smaller in diameter, it is subject to kinking which willresult in little to no force transmitted to the distal end. Kinking isespecially a problem in endoscopic instruments, as the endoscope and itslumen may be extended through a tortuous path. For these reasons andothers, mechanical application of a relatively large distal end pushingforce and particularly clip application have been absent from thecapability of flexible endoscopic tools.

SUMMARY OF THE INVENTION

[0009] It is therefore an object of the invention to provide a flexibleendoscopic device capable of generating a relatively large pushing forceat its distal end.

[0010] It is another object of the invention to provide an endoscopicclip applier.

[0011] It is a further object of the invention to provide a flexibleclip applier which can exert a pushing force of at least 500 grams (1.1lbs), and preferably in excess of 1500 grams (3.3 lbs) via a manuallyactuatable handle.

[0012] It is an additional object of the invention to provide a surgicalclip applier which is adapted for use in minimally invasive surgery.

[0013] It is also an object of the invention to provide a surgical clipapplier which has a pushing element which is not subject to kinking.

[0014] It is yet another object of the invention to provide a surgicalclip applier which has a pushing element which does not createunsuitably high frictional forces within the outer sheath.

[0015] It is still a further object of the invention to provide asurgical clip applier which can store and apply multiple clips.

[0016] In accord with these objects, which will be discussed in detailbelow, a surgical clip applier is provided having a flexible, preferablyflat wire wound outer tubular coil, a pair of jaws at the distal end ofthe tubular coil, a set of end effector wires extending through theouter tubular coil and coupled to the jaws, and a clip-advancing wireextending through the tubular coil. A lubricious, preferably extrudedpolymer, multilumen barrier sheath extends within the tubular coil andseparates the wires from each other and the tubular coil. A clip chamberis provided in the distal end of the tubular coil and stores a pluralityof linearly arranged clips. A clip pusher is provided at a distal end ofthe clip-advancing wire, and adapted to advance the clips in the chambertoward the jaws when the clip-advancing wire is advanced through thebarrier sheath and outer tubular coil. The jaws include clampingsurfaces which operate to compress tissue between the jaws when the jawsare closed, guides in which a distalmost clip rides distally and isadvanced over the clamped tissue when the line of clips is advanced bythe clip pusher, and a distal anvil which operates to bend a portion ofthe distalmost clip to enhance its retention on the clamped tissue. Aproximal handle is provided for movement of the clip-advancing wire andend effector wires relative to the barrier sheath to effect (1) clampingand rotation of the jaws (relative to each other and about thelongitudinal axis of the tubular coil), and (2) advancement of theclip-advancing wire to effect distal movement of a clip.

[0017] The flat wire wound tubular coil is preferred over round wire(though not necessarily required over a round wire wound tubular coil)because it is flexible, yet sufficiently longitudinally stiff such thatthe device may be pushed through the lumen of the endoscope. Inaddition, the flat wire wound tubular coil can be made with a highpreload and has a tensile spring constant sufficiently high that itresists buckling and uncoiling during application of a pushing force bythe handle against the clip-advancing wire. The clip-advancing wire hasa sufficiently large diameter to transmit force, yet small enough tominimize internal friction when moved within a device flexed through atortuous path in an endoscope. The end effector wires are large enoughto handle the high closing force from the handle, and to resistcompressive buckling when moved in an opposite direction, yet smallenough to be coupled to diminutive jaws. The multilumen barrier sheathsupports the clip-advancing wire and end effector wires along theirlength to reduce compressive buckling, and provides a separation layerto reduce friction. Movement of the clip-advancing wire relative to theouter tubular coil causes a compressive force in the clip-advancing wireand tensile forces in the outer tubular member such that a relativepushing force is transmitted to the distal end of the clip-advancingwire in excess of the perceived threshold of the 200 grams (0.44 lbs).In fact, one embodiment of the device of the invention, sized forendoscopic use, provides a pushing force in excess of 2267 grams (5lbs).

[0018] In operation, the jaws can be moved through a working channel ofan endoscope in a closed position. Once exited, the handle can beoperated to open the jaws and rotate the jaws to a desired orientation.The jaws are positioned on either side of tissue about which it isdesired to place a clip and the handle is operated to pull the endeffector wires such that the jaws clamp about the tissue. The handle isthen locked to maintain the jaws in the clamped position. The handle isoperated to effect advancement of the clip-advancing wire through thetubular coil such that a clip is advanced through the jaw guides andover the tissue. The clip is advanced until a portion thereof is forcedagainst the anvil of the jaws to effect bending of the clip portion suchthat that portion moves laterally to pierce the clamped tissue. Afterthe clip is applied, the jaws are released from about the tissue, andthe end effector assembly may then be moved to another tissue locationto apply additional clips.

[0019] Additional objects and advantages of the invention will becomeapparent to those skilled in the art upon reference to the detaileddescription taken in conjunction with the provided figures.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020]FIG. 1 is a partial section side elevation view of a surgical clipapplier according to the invention, shown with the handle configured toprovide the jaws in an open configuration;

[0021]FIG. 2 is a broken perspective view of a distal portion of theclip applier according to the invention;

[0022]FIG. 2A is an exploded and broken perspective view of a distalportion of the clip applier according to the invention;

[0023]FIG. 2B is a broken schematic view of a distal end of theclip-advancing wire and the coil connector;

[0024]FIG. 2C is a broken schematic view of a distal end of theclip-advancing wire and the coil connector illustrating the limitationon proximal movement of the clip-advancing wire relative to the coilconnector;

[0025]FIG. 3 is a perspective view of the jaw assembly of the clipapplier according to the invention, and a clip;

[0026]FIG. 4 is a partial section side elevation view of a surgical clipapplier according to the invention, showing the right side of the handlepositioned to place the jaws in an unloaded closed configuration;

[0027]FIG. 4A is a view similar to FIG. 4, illustrating alternativeembodiments to the handle of the clip applier according to theinvention;

[0028]FIG. 5 is an enlarged view of the handle of the surgical clipapplier with the handle in the same position as shown in FIG. 4;

[0029]FIG. 6 is a view similar to FIG. 4 of the left side of the handle;

[0030]FIG. 7 is a view similar to FIG. 6 with the addition of thevarious springs;

[0031]FIG. 8 is an enlarged broken section view of the proximal leftside of the handle of the clip applier according to the invention;

[0032]FIG. 9 is an enlarged side perspective view of the end effectorassembly;

[0033]FIG. 10 is an enlarged distal end perspective view of the endeffector assembly;

[0034]FIG. 11 is a broken partial section side elevation view of thedistal end of the clip applier according to the invention;

[0035]FIG. 12 is a view similar to FIG. 1, showing the handle configuredsuch that the jaws are in a unloaded closed position, and shown withoutthe pinion on the jaw closing lever;

[0036]FIG. 13 is a partial section perspective view of a surgical clipapplier according to the invention, illustrating rotation of the endeffector assembly by operation of the rotation knob;

[0037]FIG. 14 is a partial section side elevation view of a surgicalclip applier according to the invention, showing the jaws in a clampedconfiguration;

[0038]FIG. 15 is a partial section side elevation view of a surgicalclip applier according to the invention, showing the jaws in a clampedconfiguration and the clip-advancing lever actuated;

[0039]FIG. 16 is an enlarged partial section view of the handle of thesurgical clip applier, showing the clip-advancing lever actuated;

[0040]FIG. 17 is a longitudinal section view of the distal end of theclip applier according to the invention, shown with the jaws in a closedconfiguration and a formed clip therebetween;

[0041]FIG. 18 is a broken partial section side elevation view of thedistal end of the clip applier according to the invention, shown withthe jaws in an open configuration and a formed clip therebetween;

[0042]FIG. 19 is a broken partial section side elevation view of thedistal end of the clip applier according to the invention, shown withthe jaws in an open configuration, the formed clip released, and theretainer of a subsequent clip protruding between the jaws;

[0043]FIG. 20 is a longitudinal section view of the distal end of theclip applier according to the invention, shown with the jaws in an openconfiguration and the retainer retracted relative to the view of FIG.19;

[0044]FIG. 21 is a partial section side elevation view of a surgicalclip applier according to the invention, shown with the jaws in an openposition and a formed clip released therefrom;

[0045]FIG. 22 is a table listing dimensions for the tubular coil,clip-advancing wire, and end effector wires of six prototypes, and theresultant output force achieved with the prototype; and

[0046]FIG. 23 is an efficiency plot of the prototypes described in thetable of FIG. 22.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0047] Turning now to FIGS. 1, 2, 2A and 3, a flexible clip applier 10suitable for insertion through a working channel (lumen) of an endoscopeis shown. The clip applier 10 generally includes a flexible, flat wirewound outer tubular coil 12 having an end effector assembly 13 mountedat a distal end 16 thereof. The end effector assembly 13 includes aclevis (jaw mount) 14 rotatably supporting a pair of jaws 18, 20. Endeffector wires 22, 24 extend through the tubular coil 12 and have distalends 26 respectively coupled to the jaws 18, 20. A clip-advancing wire30 extends through the tubular coil 12 and includes a distal end 32provided with a clip pusher 34. A lubricious, preferably extruded,multilumen barrier sheath 36 extends through substantially the entirelength of the outer tubular coil 12 and separates the end effector wires22, 24 and clip-advancing wire 30 from each other and the outer tubularcoil 12. A proximal handle assembly 40 is provided for moving the endeffector wires 22, 24 and clip-advancing wire 30 relative to the tubularcoil 12 to effect clamping and rotation of the jaws and advancement of aclip, as described in detail below.

[0048] Referring to FIGS. 4 and 5, more particularly, the handleassembly 40 includes a housing defined by two shell portions 42, 44, astationary handle 46, a jaw closing lever 48 linearly movable within aslot 50 in the housing and relative to the stationary handle 46, and aclip-advancing lever 52 rotatably mounted on the jaw closing lever 48with a pivot pin 54. The jaw closing lever 48 is coupled to the endeffector wires 22, 24, as described in detail below. The jaw closinglever 48 is biased into an open position (away from the stationaryhandle 46) with a constant force spring 56 held in a distal portion ofthe housing such that the jaws 18, 20 are in an open configuration whenno manual force is applied against the force of the spring 56 to movethe jaw closing lever toward the stationary handle. The clip-advancinglever 52 is forced into an open position, also away from the stationaryhandle 46, with a torsion spring 58 (FIGS. 4 and 7). The clip-advancinglever 52 is coupled to the clip-advancing wire 30, as discussed indetail below, with rotation of the clip-advancing lever 52 operating tomove the clip pusher 34 at the distal end 32 of the clip-advancing wire30 longitudinally within the tubular coil.

[0049] A tube 60 extends from the interior of the handle 40 to theexterior and includes a proximal rotation knob 62. The proximal end ofthe clip-advancing wire 30 is clamped, or otherwise held, within thetube 60 such that rotation of the knob 62 causes rotation of the entireclip-advancing wire. A distal end 64 of the tube 60 is rotatably coupledwithin a collar 66. The collar 66 is fixedly coupled to a rack 68.Linear movement of the rack 68 within the housing causes the tube tomove longitudinally within and outside the housing.

[0050] Alternatively, referring to FIG. 4A, the tube 60 may betelescoping, having two rotationally interfering sections 60 a and 60 b,such that movement of the rack 68 moves a distal section 60a of the tuberelative to a proximal section 60 b, thereby maintaining a constantlength for extension of the proximal section 60 b of the tube outsidethe housing. The rotationally interfering portions, e.g., each having ahex shape, permit rotationally forces to be transmitted from the knob 62to the distal end 64 of the tube.

[0051] Referring back to FIG. 4, a pinion 70 is rotatably mounted at 72to an upper portion 74 of the clip-advancing lever 52 and positioned toact on the rack 68 when the clip-advancing lever is rotated. As such,when the clip-advancing lever 52 is rotated about pivot 54 toward thejaw closing lever 48, the rack 68 and the clip-advancing wire 30 areadvanced. The rack 68 is preferably substantially longer than what isrequired by the number of teeth on the pinion 70. As a result, thepinion 70 can act upon the rack 68 in any location at which the jawclosing lever 48 may be positioned upon closing the jaws 18, 20. This,when the jaw closing lever 48 is pulled back toward the stationaryhandle 46 to effect closure of the jaws 18, 20 about tissue, the jawclosing lever 48 may be located at a location which is consistent withthe thickness and consistency of the tissue about which the jaws are tobe closed.

[0052] The teeth of the pinion 70 are preferably at a positiveengagement angle relative to the teeth of the rack 68 because of thelocation of the pinion pivot axis 72. Then, when the pinion is rotated,the rack is moved longitudinally. A leaf spring 76 acts between thepinion 70, at hole 78, and the advancing lever 52 at shelf 77 to forcethe pinion 70 into the rack 68. After firing a clip, as discussed below,release of the clip-advancing lever 52 allows the spring 58 to returnthe lever 52 back to its unbiased position, and the pinion 70 rotatesabout the pinion axis 72 against the leaf spring 76 and over the rack68.

[0053] Turning now to FIGS. 6 through 8, the jaw closing lever 48includes a spring activated catch system 80 which locks the jaw closinglever when a predetermined load is applied thereto rather than when theclosing lever is located at any particular location. The catch system 80includes the following structures on an upper mount portion 82 of thejaw closing lever 48: a proximal spring mount 84; two spaced apart bolts86, 88; and a locking tooth 90. The locking tooth 90 includes a proximalcam 92. The catch system 80 further includes the following additionalstructures: a latch 94 having a linear slot 96 and a cam slot 98, whichare positioned over bolts 86, 88 respectively; an end effector wiremount 100 to which the proximal ends of the end effector wires 22, 24are attached; an upper cam surface 102 for the below-described leverlock 110; and a spring catch 104. An extension spring 106 (FIG. 7) isheld between the spring mount 84 and spring catch 104. A generallyL-shaped lever lock 110 is rotatably coupled about a lever pivot 114formed at the proximal end of the handle. An elongate portion 116 of thelock 110 includes a comb; i.e., the portion 116 includes a plurality ofteeth 118, each of which include a distal camming surface 120. Anotherportion 122 of the lever lock 110 is provided with a release button 124which extends outside of the handle housing. A torsion spring 130 isprovided about the pivot 114 to bias the lever lock 110 down toward thelocking tooth 90. A safety 132 is also provided to prevent release ofthe jaw closing lever 48 when the clip-advancing lever 52 is moved froman unbiased position, thereby preventing inadvertent release ofunapplied clips.

[0054] Once the jaws are closed about tissue, as discussed furtherbelow, it is desired to maintain their closed position until a clip isadvanced over the tissue. In view of this object, the catch system 80function as follows. Still referring to FIGS. 6 through 8, the camsurface 102 is generally adapted to position the teeth 118 of the leverlock 110 located in front of the locking tooth 90 above the lockingtooth, such that the jaw closing lever 48 may be moved linearly. Whenthe jaw closing lever 48 is moved toward the stationary lever 46,tension is increased in the end effector wires 22, 24 to move the jaws18, 20 from an open position to a closed position. As the tensionincreases in the end effector wires 22, 24 and exceeds the tension ofthe extension spring 106, the latch 94 moves distally relative to thejaw closing lever 48. Then, movement of the jaw closing lever 48relative to the latch 94 causes the bolts 86, 88 to ride within thelinear slot 96 and the camming slot 98, respectively. Referring to FIG.8, movement of bolt 88 within camming slot 98 forces the proximal end ofthe latch 94 downward and permits the lever lock 110 to rotateclockwise. This causes the locking tooth 90 to engage the toothedportion 116 of the lever lock 110 and lock the position of the jawclosing lever 48. The load applied to the end effector wires is thenlimited to the force applied by the extension spring 106 (FIG. 7). Thejaw closing lever 48 then may be released by pushing the release button124 sufficiently to rotate the lever lock 110 against the bias of thetorsion spring 130 and clear the locking tooth 90.

[0055] Turning now to FIGS. 1, 2, 4 and 6, the distal end of the housing42, 44 of the handle assembly 40 includes a slot 131 in which twopreferably substantially rigid and preferably low friction tubes 133,135, e.g., brass tubes, are provided. The proximal end 136 of thetubular coil 12 is coupled to the housing in alignment with the tubes133, 135 with a flare nut coupling 138 or an equivalent assembly. Theclip-advancing wire 30 extends from the rotation tube 60 through tube133 and into a clip-advancing wire lumen 140 of the barrier sheath 36.The clip-advancing wire 30 extends therethrough to the distal end 16 ofthe tubular coil 12. The end effector wires 22, 24 extend from endeffector wire mount 100 through tube 135 and into respective endeffector wire lumina 142, 144 of the barrier sheath 36, and then extendtherethrough to the distal end of the tubular coil. Wires 22, 24 and 30are provided in separate lumina within the barrier sheath 36 in order tominimize friction between the wires and reduce buckling and kinking ofthe wires along the length of the tubular coil 12.

[0056] Turning again to FIG. 4A, rather than using tubes to direct thewires from the housing into the barrier sheath in tubular coil, thehousing may be formed with channels which provide the same function. Forexample, channels 132 a, 132 b are adapted to direct the clip-advancingwire 30 and end effector wires 22, 24, respectively, into the barriersheath 36 within the tubular coil 12. In addition, the housing may beformed with distal structure, e.g., a cylindrical protrusion 146,facilitating the coupling of a flare nut assembly thereto.

[0057] Referring back to FIG. 2, the tubular coil 12 is a preferablystainless steel (or other metal or metal alloy) flat wire wound wiretubular coil, though a round wire wound tubular coil may be used. Thetubular coil 12 is fairly stiff such that the device can be pushedthrough the endoscope to the treatment area. The tubular coil 12 has aspring constant sufficiently high in order to resist uncoiling whensubject to the tensile load created when the handle applies a pushingforce to the clip-advancing wire and the clips, as discussed in moredetail below, and minimize buckling during force transmission. Inaddition, the tubular coil 12 is preloaded such that each turn issubstantially in contact with the adjacent turns 360° around the tubularcoil. The outer diameter of the tubular coil 12 has an outer diametersmaller than the inner diameter of the working channel (lumen) of anendoscope for which it is intended, and the inner diameter of thetubular coil should be maximized so that it may readily accept thebarrier sheath, and clip-advancing wire and end effector wires, as wellas form a chamber for a plurality of clips, as discussed below. Inpreferred embodiments, the tubular coil 12 of a device adapted for anendoscope having a 3.2 mm working channel has an outer diameterpreferably not exceeding approximately 3.175 mm (0.125 inch), and apreferably an inner diameter of at least approximately 0.90 mm (0.035inch) so that it may accept the end effector wires 22, 24,clip-advancing wire 30, barrier sheath 36, and clips 202. The tubularcoil inner diameter preferably corresponds to the transverse dimensionof a clip 202, discussed below, so that the clip is stably directedthrough the chamber 200. The wire of the tubular coil 12 has a width Wpreferably between approximately 0.635 mm to 1.270 mm (0.025 inch to0.050 inch), and a thickness T preferably at least approximately 0.13 mmto 0.75 mm (0.005 inch to 0.030 inch). The tubular coil length should atleast be the length of the endoscope working channel, generally 150 cmto 250 cm. A substantial length of the tubular coil 12 is preferablycovered in a high density polyethylene (HDPE) sheath 150 (FIGS. 1, 2 and2A).

[0058] The barrier sheath 36 within the tubular coil is preferablynon-circular in shape to reduce contact points and thereby minimizefriction between the barrier sheath and the tubular coil. The primarypurpose of the sheath is to maintain a close fitting bearing surface forthe clip-advancing wire, although its three distinct lumina help reducefriction between all the wires. The sheath 36 preferably free floatswithin the tubular coil; i.e., it is not attached to the tubular coil atits ends or along its length. Preferred cross-sectional shapes includegenerally rectangular and triangular (each with or without broken orrounded edges) and trefoil. The barrier sheath 36 is preferably anextrusion made from polypropylene, an FEP fluoropolymer resin (FEP),polytetrafluoroethylene (PTFE), high density polyethylene (HDPE), nitrolpolyvinyl chloride, nylon, or any other lubricious polymer.

[0059] The clip-advancing wire 30 is preferably made of nickel-titaniumalloy (NiTi) or stainless steel. The NiTi construction permits theclip-advancing wire 30 to transmit torque (by rotation of the rotationknob 62) without taking a cast, and with minimal whipping. Theclip-advancing wire 30 has a sufficiently large diameter to transmitforce, yet not so large that it is prevented from functioning through atortuous path or fit within the tubular coil 12. A preferred diameterfor the clip-advancing wire is approximately 0.375 mm to 0.89 mm (0.015inch to 0.035 inch).

[0060] Referring to FIGS. 2, 2A and 2B, the distal end 32 of theclip-advancing wire 30 has a non-circular cross-section, and ispreferably rectangular in shape. The distal end 32 is preferably alength four to five times the length of the clip pusher 34. A coilconnector 152 is coupled within the distal portion 16 of the tubularcoil 12, e.g., by welding, press fitting, interference fit, pinning,etc., preferably approximately 25 mm to 50 mm from the distal end of thetubular coil (i.e., the length of a linear arrangement of five or soclips), and includes a central keyhole 156 having a non-circular crosssection, and two end effector channels 158 (only one shown) throughwhich the end effector wires 22, 24 extend. The distal end 32 of theclip-advancing wire 30 can be longitudinally moved through the keyhole156, with the transition 159 of the clip-advancing wire 30 fromnon-circular to circular outer shape functioning as a stop against thekeyhole 156 for additional distal movement.

[0061] Referring to FIG. 2B, the distal end 32 of the clip-advancingwire 30 also includes notches 250 along one side 251 of the distal end32 which have a distal surface 252 substantially perpendicular to theside 251 and proximal beveled surface 254. The coil connector 152includes a resilient catch 256 in alignment with the notches 250. Whenthe clip-advancing wire 30 is moved distally through the keyhole 156,the beveled surface 254 of the notches 250 rides against the catch 256,bending the catch for clearance. However, as distal surface 252interferes with the catch 256 when the clip-advancing wire 30 is movedproximally relative to the coil connector 152, the clip-advancing wire30 may not be moved proximally by a distance which would cause a notch250 to pass the catch 256 (FIG. 2C).

[0062] Moreover, rotation of the clip-advancing wire 30 causes arotational moment to be applied to the connector 152 and consequentlythe distal end of the tubular coil 12. The distal end of the preloadedtubular coil 12 can be thereby rotated 360° in each of the clockwise andcounterclockwise directions by rotation of the rotation knob 62 attachedto the proximal end of the clip-advancing wire 30. Because the endeffector assembly 13 is attached to the distal end of the tubular coil,rotation of knob 62 effects rotation of the end effector assembly 13 andthe jaws 18, 20.

[0063] The end effector wires 22, 24 are large enough in diameter topreferably handle up to fifteen pounds of closing force from the handleassembly and also to handle the force required to open the jaws 18, 20without buckling. However, the end effector wires must be small enoughin diameter to attach to the jaws, and fit in the tubular coil 12. Apreferred diameter for the end effector wires is approximately 0.178 mmto 0.375 mm (0.007 inch to 0.015 inch), though other sizes may be used.

[0064] Referring to FIGS. 9 and 10, the clevis 14 of the end effectorassembly 13 is preferably coupled directly to the distal end of thetubular coil 12. The clevis 14 includes a central clip channel 164having a preferably rectangular cross section, and two lateral openings165 through which the distal ends of the end effector wires 26, 28 canrespectively exit. The jaws 18, 20 are each rotatably coupled about theclevis 14 with a respective axle 166 (one shown) which does notinterfere with the channel 164. Each jaw 18, 20 includes a proximal tang168, 169 respectively, which is coupled to the distal ends of therespective end effector wires 26, 28. The distal portion of each jaw 18,20 includes a clip guide 170, 172, respectively, and clamping surfaces174, 176 on jaw 18, and clamping surfaces 178, 180 on jaw 20 extendingalong each side of the guide 172. All of the clamping surfaces 174, 176,178, 180 preferably have proximally directed teeth 182 which pullstarget tissue toward the clip channel 164 as the jaws are closed, andalso securely grips the tissue when a clip is advanced thereover. Thedistal end of jaw 18 includes an anvil 184 which is in alignment withthe clip guide 170 which curves (or is angled) toward jaw 20. Jaw 20includes two distal anvil guides 186, 188 between which the anvil 184 ispositioned when the jaws are moved to a closed position. Jaw 20 alsodefines a distal well 190 between the anvil guides 186, 188 which islower than the surface of clip guide 172.

[0065] Referring to FIG. 11, a clip chamber 200 for storing a pluralityof linearly arranged clips 202 (FIG. 2A), described further below, isformed between the coil connector 152 (FIGS. 2 and 2A) and the distalend 16 of the tubular coil 12. The clip chamber 200 extends into theclip channel 164 of the clevis 14. The clip pusher 34 is provided at theproximal end of the chamber and situated to push on a proximalmost clipsuch that all clips in front of the clip pusher 34 are advanced towardthe jaws 18, 20 when the clip-advancing lever 52 is actuated to causethe clip-advancing wire 30 to move distally relative to the tubular coil12.

[0066] The clip pusher 34, preferably made of stainless steel, iscoupled to the distal end 32 of the clip-advancing wire 30, e.g., bymechanical joining or welding. The clip pusher 34, as described in moredetail below, is provided. with a shape substantially similar to thedistal portion of a clip 202 (FIG. 2A) adapted to be used in the clipapplier. Such clips 202 are described in detail in previouslyincorporated U.S. Ser. No. 09/891,775. Generally, referring to FIG. 2A,the clips 202 are each in a generally U-shaped configuration with firstand second arms 204, 206, and a bridge portion 208 therebetween. Thefirst arm 204 extends into a deformable retainer 214 preferably having atissue-piercing end 216 and preferably also a hook 218, and the secondarm 206 is provided with a tip 210 preferably having one or more catches212. The clip 202 is provided with structure that facilitates thestacking (or chaining) of a plurality of clips in the clip chamber 200.The structure includes: a notch 220 at a junction of the second arm 206and the bridge portion 208 which is adapted to receive the tip 210 ofthe second arm 206 of another clip; an elongate recess 222 along theexterior of the first arm 204 which is adapted to receive the retainer214 of the first arm of another clip; and an interior configuration 224at the ends of the first and second arms which corresponds to anexterior shape of the proximal bridge portion 208 of another clip. Inone embodiment, the clips 202 are each approximately 6.86 mm (0.27 inch)in length from the bridge 208 to the end of the retainer 214, have awidth of approximately 0.90 mm (0.035 inch), and a height of 1.80 mm(0.070 inch). However, it is understood that the clip dimensions may beadapted for use in devices having tubular coil inner diameters ofvarious sizes.

[0067] Referring to FIGS. 2 and 2A, the clip pusher 34 includes a rearclip seat 228 which corresponds to the exterior shape of the proximalend of the clip. The clip pusher 34 also includes a distally extendingarm 230 having a distal clip catch 232 (adapted to seat in the recess222 of clip 202), and a shoulder 234 adjacent the clip seat 228 on theside opposite the arm 230. As such, the clip pusher 34 includesstructure which is adapted to conform the proximal end of a clip 202 fortransferring a pushing force relative to the tubular coil. In addition,the clip catch 232, by engaging in the recess 222 of a clip 202,prevents clips from unintentionally moving distally. The clip catch alsopermits moving a clip 202 proximally, by retracting the clip pusher 34such that the clip catch 232 forces back against wall at the rear of therecess 222 and pulls the engaged clip proximally, which in turn movesother clips in the ‘chain’. The operation of the distal portion of thedevice 10 (including the end effector assembly 13, the clip pusher 34,and the clip chamber 200) will become evident with reference to thefollowing description of the use of the device 10.

[0068] Referring to FIGS. 4 and 12, the jaw closing lever 48 is movedtoward the stationary handle 46, against the bias of spring 56, to causethe jaws 18, 20 of the end effector 13 to move into a closed position.Movement of the lever 48 adapts, in size, the distal end of the devicefor delivery through the lumen (working channel) of an endoscope, butpreferably does not substantially load the end effector wires 22, 24.Once the end effector assembly 13 has exited the distal end of theendoscope, the jaw closing lever 48 can be released to open the jaws(FIG. 1). Referring now to FIG. 13, the proximal rotation knob 62 can berotated which, as discussed above, effects rotation of the entireclip-advancing wire 30 and, hence, rotation of the end effector assembly13. Briefly, this is because the end effector assembly 13 is coupled tothe tubular coil 12 and the tubular coil is provided with a fixed coilconnector 152 which is rotated by rotation of the distal end 32 of theclip-advancing wire 30.

[0069] Turning now to FIG. 14, once the jaws 18, 20 of the end effectorassembly 13 are positioned on either side of tissue (not shown) aboutwhich it is desired to place a clip 202 (FIGS. 2 and 2A), the jawclosing lever 48 is again moved toward the stationary handle 46 to clampthe jaws about the tissue. The lever 48 is moved relatively further thanshown in FIG. 12, as the wires 22, 24 will be under load to compress thetissue. Referring back to FIGS. 9 and 10, the teeth 182 on the clampingsurfaces 174, 176, 178, 180 of the jaws 18, 20 are angled proximally topull the tissue into the jaws assembly and securely hold the tissueagainst the distally directed force of an advanced clip. As the jawsclose, the anvil 184 moves between the anvil guides 186, 188, and maypartially or fully pierce the tissue.

[0070] Once the jaws are fully clamped about the tissue, the lockingtooth 90 engages with the lever lock 110 as the latch 94 moves down toallow engagement and thereby lock the jaw closing lever 48 relative tothe stationary handle 46, as discussed above with respect to FIGS. 6 and7. As discussed above, the jaws are locked based upon the load in thehandle, rather than at any particular position. This permits locking thejaws about tissues of various thicknesses and compressive properties.Moreover, it is noted that when the jaws 18, 20 are fully clamped, theend effector wires 22, 24 are placed under tension which providescompression to the tubular coil 12 such that the coil has an effectivelyhigher tensile limitation before stretching.

[0071] Referring now to FIGS. 15 and 16, after the jaws are clampedabout the tissue, the clip-advancing lever 52 is rotated about the pivotpin 54 to effect advancement of the clip-advancing wire 30 through thetubular coil 12. More particularly, as lever 52 is rotated toward thejaw closing lever 48, the pinion 70 engages the rack 68 to move the rackrelatively distally. As the proximal end of the clip-advancing wire 30is longitudinally fixed relative to the rack 68, the distal end 32 ofthe clip-advancing wire 30 is consequently moved distally. Referring toFIGS. 10 and 17, the pusher 34, at the distal end 32 of theclip-advancing wire 30 distally advances the clips 202 a, 202 b, 202 c,202 d in the chamber 200, and particularly forces the distalmost clip202 a through the channel 164 in the clevis 14 and between the jaws 18,20. As clip 202 a is further advanced, the first and second arms 204,206 ride in guides 170, 172, respectively, and are forced over thetissue held between the jaws 18, 20. When the retainer 214 on the firstarm 204 of the clip 202 a is forced against the anvil 184, the retainer214 is bent toward jaw 20; the tip 216 pierces the tissue between thejaws 18, 20 (or is guided into the pierce hole made by the anvil 184when the jaws clamped the tissue); and the tip 216 enters the well 190at the distal end of jaw 20 to extends around the tip 210 of the secondarm 206 which overhangs the well. The hook 218 at the tip 216 of theretainer 214 may engage (although it does not necessarily engage), thelatch 212 at the distal end of the second arm 206. The force provided bythe clip-advancing wire 30 to advance a clip 202 over the clampedtissue, to bend the retainer 214 against the anvil 184, and to force thetip 216 of the retainer to pierce tissue is at least 500 grams (1.1lbs), and more typically approaches 1500 grams (3.3 lbs) or higher.

[0072] Referring now to FIGS. 6 and 18, after the clip is applied, thejaws 18, 20 are released from about the tissue. This is done by pressingthe release button 124 of the lever lock 110 such that the jaw closinglever 48 is permitted to move relative to the stationary handle 46.

[0073] Referring to FIG. 19, the clip is then released from the endeffector jaw assembly by moving the jaw assembly relative to the appliedclip 202 a.The end effector assembly may then be moved to another tissuelocation to apply additional clips.

[0074] It is noted that after clip 202 a is released, the retainer 214 bof clip 202 b partially extends into the space between the jaws 18, 20.If not retracted, this retainer 214 b would obstruct positioning thejaws 18, 20 about the tissue and subsequent clip application during theprocedure. However, when the clip-advancing lever 52 is released,torsion spring 58 (FIG. 4) operates to pull back the clip-advancing wire30 and the clip pusher 34 and thereby retract the ‘chain’ of clips. Thatis, the clip catch 232 of the clip pusher pulls back on clip 202 d, andthe retainer 214 d of clip 202 d pulls back clip 202 c, and so on, untilthe extending retainer 214 b is pulled within the chamber 164 of theclevis, and the space between the jaws 18, 20 is cleared, as shown inFIGS. 20 and 21. The clip-advancing wire is limited in the distance bywhich it can be retracted; it may be retracted only so far as permittedby interference of a ridge 250 on the clip-advancing wire 30 locatedjust distal the catch 256 of the coil connector 152, and the catch 256(FIG. 2B), which is constructed to be approximately the length of theprotruding retainer 214b.

[0075] The device may then be used to apply another clip, or the jawsmay be closed and the device may be withdrawn through the endoscope.

[0076] The resulting clip applier is capable of transmitting a pushingforce at the distal end of the clip-advancing wire, resulting from thecompressive force appliable to the clip-advancing wire and the relativetensile force appliable to the outer tubular coil and end effectorwires, far in excess of the perceived threshold of the 200 grams (0.44lbs) in the prior art. In fact, as discussed below, one embodiment ofthe device of the invention provides a pushing force in excess of 2267grams (5 lbs).

[0077] More particularly, referring to FIG. 22, a table listing partdimensions of six prototype device, and the resultant output forcesachieved with prototype devices is provided. FIG. 23 provides anefficiency plot (input pushing force v. output pushing force) for theuse of the prototypes. In all prototypes, the tubular coil,clip-advancing wire, and end effector wires are made from stainlesssteel. Details of the table and the efficiency plot are discussed belowwith respect to Examples 1 through 6.

EXAMPLE 1

[0078] In a first prototype, indicated by ‘RUN #1’, ‘RUN #2’ and ‘RUN#3’, the tubular coil 12 has an outer diameter of 0.09 inch and an innerdiameter of 0.06 inch. The clip-advancing wire 30 has an outer diameterof 0.017 inch and the end effector wires 22, 24 each have an outerdiameter of 0.011 inch. The proximal end of the end effector wires 22,24 are pulled with 11 lbs of force which generally results in 5 to 10lbs of force at the distal end of the end effector wires, depending onthe degree to which the tubular coil 12 is bent (modeled by looping thetubular coil through two inch loops); i.e., frictional losses reduce thetransmitted force. Moreover, it is noted that whatever force istransmitted to the distal end of the end effector wires 22, 24, onlyapproximately one-fifth of that force is applied to the jaws, as thedistance from the jaw tang 168 to the pivot 166 is relatively shorterthan the length of the end of the jaw (anvil 184) to the pivot 166,approximately in a one to five ratio. As such, an input force of 11 lbsmay results in one to two lbs of force on the jaws 18, 20. Applying thepulling force simulates the in-use condition in which the pushing forceis transmitted.

[0079] With the tubular coil 12 extending relatively straight (i.e.,through no loops) in ‘RUN #1’, an input pushing force of 8 lbs on theproximal end of the clip-advancing wire 30 (i.e., a pushing force of 8lbs on the rack 68) resulted in an output pushing force of 3.82 lbs(1732.7 grams) at the clip pusher 34 at the distal end 32 of theclip-advancing wire 30. With the tubular coil 12 extending through onetwo-inch loop in ‘RUN #2’, an input pushing force of 8 lbs resulted inan output pushing force of 3.42 lbs (1551.3 grams). With the tubularcoil 12 extending through two two-inch loops, in ‘RUN #3’, an inputpushing force of 7 lbs resulted in an output pushing force of 3.37 lbs(1528.6 grams).

EXAMPLE 2

[0080] In a second prototype, indicated by ‘RUN #4’, the diameters ofthe tubular coil 12 and end effector wires 22, 24 are the same asExample 1. However, the diameter of the clip-advancing wire 30 isdecreased to 0.015 inch. With the tubular coil 12 extending through noloops, a six pound input pushing force resulted in an output pushingforce of 2.11 lbs (957 grams).

EXAMPLE 3

[0081] In a third prototype, indicated by ‘RUN #5’, ‘RUN #6’ and ‘RUN#7’, the diameters of the tubular coil 12 and end effector wires 22, 24are the same as Example 1. However, the diameter of the clip-advancingwire 30 is increased to 0.02 inch. With the tubular coil 12 extendingthrough no loops in ‘RUN #5’, an input pushing force of 8 lbs resultedin an output pushing force of 4.03 lbs (1828 grams). With the tubularcoil 12 extending through one two-inch loop in ‘RUN #6’, an inputpushing force of 8 lbs resulted in an output pushing force of 4.08 lbs(1851 grams). With the tubular coil extending through two two-inchloops, in ‘RUN #7’, an input pushing force of 8 lbs resulted in anoutput pushing force of 3.54 lbs (1605.7 grams).

EXAMPLE 4

[0082] In a fourth prototype, indicated by ‘RUN #8’ and ‘RUN #9’, thedevice includes a tubular coil 12 having an outer diameter of 0.086 inchand an inner diameter of 0.053 inch, a clip-advancing wire 30 having adiameter of 0.017 inch, and end effector wires 22, 24 having diametersof 0.009 inch. With the tubular coil extending through no loops, aninput pushing force of 8 lbs resulted in 4.61 lbs (2091 grams) of outputpushing force. With the tubular coil extending through two two-inchloops, an input pushing force of 8 lbs resulted in 4.28 lbs (1941.3grams) of output pushing force.

EXAMPLE 5

[0083] In a fifth prototype, indicated by ‘RUN #10’, the clip-advancingwire 30 and end effector wires 22, 24 of the device 10 have the samediameters as Example 4. The tubular coil 12 has an outer diameter of0.086 inch and an inner diameter of 0.054 inch. With the tubular coil 12extending through no loops, an input pushing force of 8 lbs resulted in4.42 lbs (2004.9 grams) of output pushing force.

EXAMPLE 6

[0084] In a sixth prototype, indicated by ‘RUN #11’, the clip-advancingwire 30 and end effector wires 22, 24 of the device 10 have the samediameters as Example 4. The tubular coil 12 has an outer diameter of0.083 inch and an inner diameter of 0.054 inch. With the tubular coil 12extending through no loops, an input pushing force of 8 lbs resulted in5.17 lbs (2345 grams) of output pushing force.

[0085] Other flexible clip appliers suitable for use through arelatively smaller 2.6 mm diameter endoscope have also been constructedand tested. For example, one clip applier has a tubular coil 12 with anouter diameter of 0.092 inch, and an inner diameter of 0.060 inch, aclip-advancing wire 30 with a diameter of 0.022 inch, and end effectorwires 22, 24 each with a diameter of 0.013 inch. The device can apply apushing force of between 3 lbs (1361 grams) and 5 lbs (2268 grams)depending on the number of two-inch loops through which the tubular coilwas wound.

[0086] It is therefore appreciated that other dimensions may be used fordevices intended for use in endoscopes having working channels of othersizes. Moreover, the device may be used outside an endoscope, where itis not limited by the size of the working channel.

[0087] From the foregoing examples, it will be appreciated that aflexible surgical clip applier, suitable for use through an endoscope ishereby provided. The device is capable of effecting a pushing force farin excess of the previously considered limitation of approximately 200grams for a mechanical system sized to be used through an endoscope. SeeC. Paul Swain, “What Endoscopic Accessories Do We Really Need?”,Emerging Technologies in Gastrointestinal Endoscopy, Gastrointest.Endosc., Vol. 7, No. 2, pp. 313-330 (April 1997), discussed above. Thissubstantial force permits clips to be forced over tissue and therebymakes available clip clamping, closure, and ‘suturing’ in an endoscopicprocedure.

[0088] There have been described and illustrated herein embodiments of aflexible surgical clip applier. While particular embodiments of theinvention have been described, it is not intended that the invention belimited thereto, as it is intended that the invention be as broad inscope as the art will allow and that the specification be read likewise.Thus, while particular materials have been disclosed, it will beappreciated that other materials can be used as well. In addition, whileparticular dimensions have been disclosed, it will be understood thatother suitable dimensions can be used as well. Also, while the devicehas particularly been described for use in endoscopic procedures, wherea great need exists for such a device, it will be appreciated thatflexible, non-endoscopic devices are considered within the scope of theinvention. For example, the tubular coil may have a substantiallyshorter length and the device may be used through body orifices such asthe ear canal, the nasal passages, and through the larynx and trachea.By way of another example, elements of the device may have substantiallylarger dimensions and the device can be used through a trocar port.Furthermore, while both jaws are shown rotatable about a clevis, it willbe appreciated that only one jaw need be rotatable relative to theother. Also, while two clip guides, one on each jaw, are shown, it isrecognized that only a single clip guide on one of the jaws is required.Moreover, while the device of the invention is described as having twoend effector wires, it will be appreciated that a single control wiremay be used which is coupled to at least one of the jaws, and the otherjaw may be stationary or mechanically linked to also close and open uponactuation of the single end effector wire. Also, while the device hasbeen described with respect to a clip-advancing wire and end effectorwires, it will be appreciated that reference to the ‘wires’ is intendedto also include non-metal filaments, multifilamentary constructs, suchas cables, and coils. In addition, while the end effector wires whensubject to a tensile force create a compressive force on the tubularcoil which effectively increases its tensile capability to facilitatepushing a clip over clamped tissue without exceeding the tensilelimitation of the coil, it is recognized that other mechanisms may beused to increase the tensile limitation of the coil. For example, apreferably flat and preferably wire ribbon may be coupled to the insidethe coil to limit the amount by which the coil can be stretched.Furthermore, while the ability to provide a relative high pushing forceat the distal end of a clip-advancing wire is disclosed with respect toa clip applier, it is recognized that such capability has application toinstruments other than clip appliers; for example, for endoscopicstaplers, lithotriptors, or any other instrument where it is desired tohold tissue and apply a pushing force, such as a device for tagging. Itwill therefore be appreciated by those skilled in the art that yet othermodifications could be made to the provided invention without deviatingfrom its spirit and scope as claimed.

What is claimed is:
 1. A flexible surgical instrument, comprising: a) aflexible outer tubular member having proximal and distal ends anddefining a longitudinal axis; b) a flexible torqueable member extendingthrough said tubular member and having proximal and distal ends; c) anattachment means for rotationally securing said flexible torqueablemember to a distal end of said tubular member; and e) a handle assemblycoupled to said proximal ends of said tubular member and said flexibletorqueable member and adapted to torque said proximal end of saidflexible torqueable member relative to said tubular member which,through said attachment means, causes said distal end of said outertubular member to rotate and thereby rotates said end effector assemblyrelative to said longitudinal axis of said outer tubular member.
 2. Aflexible surgical instrument according to claim 1, wherein: said tubularmember is a tubular coil.
 3. A flexible surgical instrument according toclaim 1, wherein: said tubular coil is a flat wire wound coil.
 4. Aflexible surgical instrument according to claim 1, wherein: saidattachment means includes a connector fixedly coupled with said distalend of said tubular member, said connector defining a keyhole, and a keyelement provided at said distal end of said flexible member, said keyelement extending through said keyhole and defining a rotationallyinterfering key for said keyhole.
 5. A flexible surgical instrumentaccording to claim 4, wherein: said key element of said flexibletorqueable member is longitudinally movable relative to said keyhole ofsaid connector.
 6. A flexible surgical instrument according to claim 4,wherein: said connector includes a catch, and said flexible torqueablemember includes a plurality of structures which interfere with saidcatch when any one of said structures is attempted to be movedproximally relative to said catch to thereby substantially preventproximal movement of said flexible torqueable member a distance whichwould cause one of the structures located distal of the catch to bemoved proximal of said catch.
 7. A flexible surgical instrumentaccording to claim 6, wherein: said catch permits movement of saidstructures distally past said catch.
 8. A flexible surgical instrumentaccording to claim 1, wherein: said tubular member is a coil including aplurality of turns, and said coil is preloaded such that each turn insaid coil is substantially in contact with an adjacent turn 360° aroundsaid coil.
 9. A flexible surgical instrument according to claim 1,further comprising: f) an inner sheath extending within said tubularmember between said handle and said connector, said sheath having anon-circular cross-section and including a lumen through which saidflexible torqueable member extends.
 10. A flexible surgical instrumentaccording to claim 1, wherein: said flexible torqueable member islongitudinally movable relative to said attachment means.
 11. A flexiblesurgical instrument according to claim 1, wherein: said handle assemblyincludes a stationary handle and a rotation knob extending relative tosaid stationary handle, said rotation knob also being coupled to saidproximal end of said flexible torqueable member, wherein rotation ofsaid knob causes a torque to be applied to said proximal end of saidflexible torqueable member.
 12. A flexible surgical instrument accordingto claim 11, wherein: said rotation knob is telescopically coupled tosaid proximal end of said flexible torqueable member, such that whensaid flexible torqueable member is moved longitudinally through saidtubular member, said rotation knob remains at a fixed extension relativeto said stationary handle.
 13. A flexible surgical instrument accordingto claim 1, further comprising: f) an end effector assembly coupled tosaid distal end of said tubular member; and g) at least one end effectorcontrol element extending through said tubular member and havingproximal and distal ends, said distal end coupled to said end effectorassembly and said proximal end coupled to said handle assembly, saidhandle assembly being adapted to move said at least one end effectorcontrol element relative to said tubular member to effect operation ofsaid end effector assembly.
 14. A flexible surgical instrument accordingto claim 13, wherein: said end effector assembly includes a jaw mountdefining a channel, and a pair of jaws, at least one of said jaws ofsaid pair of jaws being rotatable on said jaw mount relative to theother of said jaws.
 15. A flexible surgical instrument according toclaim 14, further comprising: h) a clip chamber formed by at least oneof said tubular member and said end effector assembly, said clip chamberadapted to store at least one surgical clip, wherein when said handle isoperated to cause said flexible torqueable member to be forced distallyrelative to said tubular member, sufficient force is provided by saidflexible torqueable member to move a surgical clip over the clampedtissue.
 16. A flexible surgical instrument according to claim 15,wherein: said clip chamber is at least partially formed by said tubularmember, and is adapted to store a plurality of clips.